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This study is a prospective comparative, randomized, single center study to assess agreement and precision of the Optos P200TE in comparison to the predicate device in normal subjects, subjects with glaucoma, and subjects with retinal disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optical Coherence Tomography (OCT) | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optos P200TE | Device | The P200TE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device. |
| Measure | Description | Time Frame |
|---|---|---|
| Limit of Agreement (LOA) between the Optos P200TE and predicate device measurements of full retinal thickness (μm). | At the end of Visit 1 or optional Visit 2 (each visit is 1 day) | |
| Limit of Agreement (LOA) between the Optos P200TE and predicate device measurements of retinal nerve fiber layer thickness (μm). | At the end of Visit 1 or optional Visit 2 (each visit is 1 day) | |
| Limit of Agreement (LOA) between the Optos P200TE and predicate device measurements of ganglion cell complex thickness (μm). | At the end of Visit 1 or optional Visit 2 (each visit is 1 day) | |
| Limit of Agreement (LOA) between the Optos P200TE and predicate device measurements of optic disc (area, volume, cup-to-disc ratio). | At the end of Visit 1 or optional Visit 2 (each visit is 1 day) | |
| Precision between the Optos P200TE and predicate device measurements of full retinal thickness. | At the end of Visit 1 or optional Visit 2 (each visit is 1 day) | |
| Precision between the Optos P200TE and predicate device measurements of retinal nerve fiber layer thickness. | At the end of Visit 1 or optional Visit 2 (each visit is 1 day) | |
| Precision between the Optos P200TE and predicate device measurements of ganglion cell complex thickness. | At the end of Visit 1 or optional Visit 2 (each visit is 1 day) | |
| Precision between the Optos P200TE and predicate device measurements of optic disc (area, volume, cup-to-disc ratio). |
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Inclusion Criteria for Normal Group
Subjects 22 years of age or older on the date of informed consent
Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
Subjects with normal eye examinations in both eyes on the date of the study visit as observed with a 90 diopter lens
BCVA 20/40 or better (each eye) on the date of the study visit
Exclusion Criteria for Normal Group
Subjects unable to tolerate ophthalmic imaging
Subjects with ocular media not sufficiently clear to obtain acceptable OCT images in either eye
Presence of any ocular pathology except for cataract in either eye
History of leukemia, dementia or multiple sclerosis
Inclusion Criteria for Glaucoma Group
Subjects 22 years of age or older on the date of informed consent
Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
BCVA 20/40 or better in the study eye
History of Visual field defects within the previous six (6) months from the study visit or measured the day of the study visit consistent with glaucomatous optic nerve damage with at least one of the following two findings:
Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities:
Exclusion Criteria for Glaucoma Group
Subjects unable to tolerate ophthalmic imaging
Subjects with ocular media not sufficiently clear to obtain acceptable OCT images in the study eye
No reliable Humphrey Field Analyzer (HFA) visual field (24-2 Sita Standard, white on white) result within 6 months of the study visit, defined as fixation losses > 33% or false positives > 33%, or false negatives > 33% in the study eye
Presence of any ocular pathology except glaucoma in the study eye
History of leukemia, dementia or multiple sclerosis
Inclusion Criteria for Retina Disease Group
Subjects 22 years of age or older on the date of informed consent
Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
Subjects presenting at the site with retinal disease
BCVA 20/400 or better in the study eye
Diagnosis of some type of retinal pathology by investigator, may include, but not limited to: Macular Degeneration (including patients with drusen and geographic atropy and choroidal neovascularization), Diabetic Macular Edema, Diabetic Retinopathy, Macular Hole, Epiretinal Membrane, Central Serous Retinopathy and others
Exclusion Criteria for Retinal Disease Group
Subjects unable to tolerate ophthalmic imaging
Subject with ocular media not sufficiently clear to obtain acceptable OCT images in the study eye
Presence of glaucoma or any ocular pathology other than a retinal pathology (e.g., cornea pathology) in the study eye as determined by self-report and/or investigator assessment at the study visit;
History of leukemia, dementia or multiple sclerosis
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New England Retina Consultants | Springfield | Massachusetts | 01107 | United States |
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| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D009798 | Ocular Hypertension |
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| Predicate Device | Device | The predicate device is an optical coherence tomography system intended for in vivo imaging, axial cross-sectional, three-dimensional imaging and measurement of anterior and posterior ocular structures. |
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| At the end of Visit 1 or optional Visit 2 (each visit is 1 day) |
| Precision of the P200TE for the super pixel grid measurements of the full retinal thickness. | At the end of Visit 1 or optional Visit 2 (each visit is 1 day) |
| Precision of the P200TE for the super pixel grid measurements of the RNFL thickness. | At the end of Visit 1 or optional Visit 2 (each visit is 1 day) |
| Precision of the P200TE for the super pixel grid measurements of GCC thickness. | At the end of Visit 1 or optional Visit 2 (each visit is 1 day) |